Chirag Dhar

Clinical Development, Translational Sciences, and Evidence Strategy

Chirag Dhar,MBBS, MAS, DPM, FAPCR

Physician-scientist advising organizations across biopharma, medtech, and diagnostics on clinical development, translational sciences, and evidence strategy.

Clinical development strategy grounded in the highest standards of safety, ethics, and data integrity.

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About

Primum non nocere

First, do no harm!

Line illustration of Hippocrates

In medical school, when I was exposed to more Latin than I ever should have been, primum non nocere, or “first, do no harm,” became the guiding light for my philosophy as a future physician. I have stayed true to this philosophy in my work as a clinical development physician-scientist. The modern bioethical principle of non-maleficence, along with the Belmont Principles established in 1979 to protect participants in biomedical research, reflects this same commitment. Nearly two decades later, ICH Good Clinical Practice became the central framework for conducting clinical trials. Here again, participant safety was central to how trials were expected to be conducted.

Staying true to that commitment, I place participant safety at the center of my work.

Experience

Experience across the development and evidence continuum

Connecting translational science with clinical development, safety, and evidence-based decision-making.

Line illustration of an mRNA therapeutic pathway

I have supported more than 25 clinical trials, spanning early development through late-stage studies in academic and industry settings. This experience includes single-center studies in the United States, India, and Australia, as well as multicenter studies conducted across global sites.

While my experience extends across the clinical development lifecycle, my particular focus is the translational-to-clinical transition and early clinical development—helping teams connect scientific rationale, nonclinical evidence, biomarkers, and safety considerations with practical first-in-human and early-stage clinical strategies.

My work spans clinical development and evidence strategy across vaccines, mRNA therapeutics, biologics, and cell & gene therapies. It has also included artificial intelligence and machine learning-enabled biomarker development and the application of biomarkers to safety, efficacy, screening, patient selection, and treatment response.

I have supported programs operating within regulatory and ethical frameworks established by the U.S. Food and Drug Administration, Australia’s Therapeutic Goods Administration and Human Research Ethics Committees, India’s Central Drugs Standard Control Organisation, and World Health Organization prequalification pathways.

Selected publicly disclosed industry affiliations: PopVax, Biological E., BE Pharmaceuticals, BioE Holdings, Zumutor Biologics, and InterVenn Biosciences.

Capabilities

Connecting evidence to practical development questions.

Focused support for teams navigating complex scientific, clinical and safety decisions.

Translational pathway from cells to a mouse, a person and a clinical document
01

Clinical Development Strategy

Turning scientific concepts into practical, evidence-driven clinical development programs.

Development plans · Study design · Endpoint, comparator and dose strategy

02

Translational Medicine & Biomarkers

Connecting disease biology, mechanism of action, biomarkers, and clinical outcomes to guide development decisions.

Translational plans · Biomarker strategy · Patient selection · Exploratory endpoints

03

Clinical Safety & Medical Monitoring

Anticipating clinical risk and building appropriate safety monitoring and mitigation into development programs.

Risk assessment · Safety monitoring plans · Adverse events of special interest · Stopping rules

04

Regulatory & Evidence Strategy

Building coherent scientific and clinical evidence to support regulatory interactions, submissions, and development decisions.

Pre-Investigational New Drug strategy · Briefing packages · Evidence integration · Agency responses

05

Medical & Regulatory Writing

Translating complex scientific and clinical information into clear, accurate, and decision-ready documents.

Clinical protocols · Investigator’s brochures · Clinical study reports · IND nonclinical sections · Publications

Selected clinical trials

Clinical-development experience across modalities and disease areas.

Clinical trials I have contributed to.

Showing 9 studies

StageStudyDisease areaTechnologyLocationRegistry
Phase 1Bivalent typhoid and paratyphoid A conjugate vaccineInfectious diseasesConjugate vaccineIndiaCTRI/2025/07/090155
Phase 1Yellow fever vaccine in healthy adultsInfectious diseasesVaccineIndiaCTRI/2025/09/094526
Phase 1Adjuvanted and non-adjuvanted meningococcal conjugate vaccinesInfectious diseasesConjugate vaccineIndiaCTRI/2025/10/096132
Phase 1Broadly-protective COVID-19 booster studyInfectious diseasesmRNA-LNP vaccineAustraliaACTRN12626000891325
Phase 1/2Nivolumab, ipilimumab and immunogenic chemotherapy in advanced NSCLCOncologymAbs and chemotherapyUnited StatesNCT04043195
Phase 2Liquid hexavalent pediatric vaccineInfectious diseasesCombination vaccineIndiaCTRI/2024/02/063223
Phase 224-valent pneumococcal conjugate vaccine in infantsInfectious diseasesConjugate vaccineIndiaCTRI/2024/11/076260
Phase 2Osimertinib plus abemaciclib in EGFR-mutant NSCLCOncologySmall-molecule targeted therapiesUnited StatesNCT04545710
BioequivalenceGeneric semaglutide in healthy adultsCardiometabolicPeptideIndia

Showing 10 studies

StageStudyDisease areaTechnologyLocationRegistry
Phase 2/3Measles-rubella vaccine in infantsInfectious diseasesCombination vaccineIndiaCTRI/2025/11/097159
Phase 3XBB.1.5 COVID-19 vaccine across pediatric and adult age groupsInfectious diseasesRecombinant RBD-subunit vaccineIndiaCTRI/2024/01/061423
Phase 3Liquid hexavalent pediatric vaccineInfectious diseasesCombination vaccineIndiaCTRI/2025/04/085479
Phase 3Adsorbed inactivated poliomyelitis vaccine in infantsInfectious diseasesInactivated vaccineIndiaCTRI/2025/05/086953
Phase 3JN.1 COVID-19 vaccineInfectious diseasesVaccineIndiaCTRI/2025/09/094477
Phase 3POISE-3: perioperative tranexamic acid and blood-pressure-management strategiesCardiometabolicSmall molecule and perioperative strategyGlobal sites including the United States and IndiaNCT03505723
Phase 3ACHIEVE: spironolactone in dialysis-dependent kidney diseaseRenalSmall moleculeGlobal sites including India and CanadaNCT03020303
Phase 3ACT: anti-inflammatory and antithrombotic therapies for COVID-19Infectious diseasesSmall-molecule combinationGlobal sites including India and CanadaNCT04324463
Phase 4PNEUBEVAX-14 in participants aged five years and olderInfectious diseasesConjugate vaccineIndiaCTRI/2025/03/083102
Phase 4ENRICH-AF: edoxaban after intracranial hemorrhage in atrial fibrillationCardiometabolicSmall-molecule anticoagulantGlobal sites including the United States and IndiaNCT03950076

Showing 6 studies

StageStudyDisease areaTechnologyLocationRegistry
ProspectiveVOCAL ovarian-cancer liquid-biopsy validationOncologyAI/ML-enabled glycoproteomic diagnosticUnited States, Australia, Malaysia and PhilippinesNCT03837327
ProspectiveNICE blood-based detection of colorectal cancer and advanced adenomasOncologyAI/ML-enabled glycoproteomic diagnosticUnited StatesNCT05445570
ProspectivePleural effusion–based diagnostics for targeted therapies in NSCLCOncologyCompanion diagnostics for small-molecule TKIsIndiaInvestigator initiated
ProspectiveNewly diagnosed, treatment-naive HIV and/or tuberculosis cohortInfectious diseasesAI/ML-enabled diagnostics and immunology biomarkersIndiaInvestigator initiated
InterventionalDawn clinical-utility study in advanced or metastatic NSCLCOncologyAI/ML-enabled glycoproteomic diagnosticUnited StatesNCT05603299
Long-term follow-upSafety follow-up after three doses of PNEUBEVAX-14Infectious diseasesConjugate-vaccine safety follow-upIndiaCTRI/2024/07/071627

Selected from public registries and institutional disclosures. Inclusion reflects professional experience and does not imply sponsor endorsement.

Selected scholarship

Research across mechanistic, translational and clinical evidence.

Complete Scholar profile
2026The Lancet Regional Health – Southeast AsiaImmunogenicity and safety of Biological E’s 14-valent pneumococcal conjugate vaccine (PNEUBEVAX 14®) administered in a 2p + 1 schedule to healthy infants2025The Lancet Regional Health – Southeast AsiaSafety and immunogenicity of booster doses of an XBB.1.5 RBD subunit COVID-19 vaccine among individuals aged 5–80 years in India2024British Journal of CancerDiagnosing and staging epithelial ovarian cancer by serum glycoproteomic profiling2021Proceedings of the National Academy of SciencesSialoglycan recognition is a common connection linking acidosis, zinc, and HMGB1 in sepsis2019Frontiers in ImmunologyFrom ‘Serum Sickness’ to ‘Xenosialitis’: Past, Present, and Future Significance of the Non-human Sialic Acid Neu5Gc
Beyond Work
Line illustration of a 1959 Austin-Healey 100-6 undergoing restoration

Away from the desk, I play squash and pickleball, swim the open-water route between La Jolla Cove and the Marine Room, and dive off Neil and Havelock Islands. I also lend a hand restoring a friend’s 1959 Austin-Healey 100-6. If any of this sounds interesting to you, let’s chat!

Get in touch

Discuss a clinical development question.

For consulting, advisory or scientific collaboration discussions across biopharma, medtech and diagnostics, please get in touch by email or LinkedIn.

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